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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01436474
Other study ID # 11-002062
Secondary ID
Status Completed
Phase Phase 1
First received June 3, 2011
Last updated January 22, 2013
Start date June 2011
Est. completion date December 2012

Study information

Verified date January 2013
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The objective of this proposal is to explore the potential of varenicline as a pharmacotherapeutic agent for opioid dependence and addiction.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date December 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility Inclusion criteria

- Age>=21 years

- Use of opioids at admission to PRC, with daily morphine equivalent dose>=60mg

- Be able and willing to participate fully in all aspects of the study including one month follow-up after completion of PRC

- Ability to provide informed consent

Exclusion criteria

- Currently using varenicline or other pharmacotherapy for nicotine dependence

- Currently pregnant, lactating, or likely to become pregnant during the trial and not willing to use an acceptable form of contraception;

- History of a major cardiovascular event in the past 6 months including unstable angina, acute myocardial infarction, stroke, or coronary angioplasty;

- Known varenicline allergy

- Use of any medication (e.g., methadone, Suboxone) as maintenance therapy for opiate addiction

- Identification of illicit drugs (e.g., marijuana, cocaine) on the baseline urine toxicology screen

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Varenicline
Patients will be randomly assigned to receive either varenicline or placebo for 45 days. Patients assigned to varenicline and are current smokers will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to varenicline and are non-smokers will receive 0.5mg by the oral route once a day for 6 days, followed by 0.5mg twice a day for 6 days. After the first 12 days the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline.
Placebo
Patients will be randomly assigned to receive either varenicline or placebo for 45 days. Patients assigned to varenicline and are current smokers will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to varenicline and are non-smokers will receive 0.5mg by the oral route once a day for 6 days, followed by 0.5mg twice a day for 6 days. After the first 12 days the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary assessment of opioid withdrawal symptoms During their treatment, patients are closely monitored by a multidisciplinary team, and there are regular assessments of pain, depression, substance use, and pain-related physical and emotional functioning 45 days Yes
Primary Assessment of cravings at one month following opioid tapering During their treatment, patients are closely monitored by a multidisciplinary team, and there are regular assessments of pain, depression, substance use, and pain-related physical and emotional functioning 45 days Yes
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